DIAGNOSIS OF ACUTE STROKES

• US 20120022349A1
• Filed: 10/07/2009
• Published: 01/26/2012
• Est. Priority Date: 10/07/2008
• Status: Abandoned Application

• Current Assignee: Orsan Medical Technologies, Ltd.
• Original Assignee: Orsan Medical Technologies, Ltd.
• Inventors: Poupko, Ben Zion, Ben-Ari, Shlomi, Rappaport, Alon
• Application Number:
  US13/122,967
• Publication Number:
  US 20120022349A1
• Time in Patent Office: Days
• US Class Current: 600/324
• CPC Class Codes: A61B 2505/01 Emergency care
• CPC Class Codes: A61B 5/02028 Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction
• CPC Class Codes: A61B 5/0261 using optical means, e.g. infrared light
• CPC Class Codes: A61B 5/0295 using plethysmography, i.e. measuring the variations in the volume of a body part as modified by the circulation of blood therethrough, e.g. impedance plethysmography
• CPC Class Codes: A61B 5/0535 Impedance plethysmography for measuring blood flow A61B5/0295
• CPC Class Codes: A61B 5/4064 Evaluating the brain A61B5/031, A61B5/369, A61B5/14553 take precedence
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/6814 Head
• CPC Class Codes: A61B 5/7239 using differentiation including higher order derivatives
• CPC Class Codes: A61B 5/7242 using integration
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B

Abstract

A method of evaluating patients suspected of suffering from an acute stroke, the method comprising:

• • a) obtaining signals of impedance plethysmography (IPG), photoplethysmography (PPG) or both, in the patient;
  • b) processing the one or more signals to obtain one or more measures of cerebral hemodynamics of the patient; and
  • c) applying a rule to match said measures to a disease indication or choice of therapy or both, for the patient.

Claims

1. A method of analyzing signals from a patient suspected of suffering from an acute stroke, the method comprising:

a) processing one or more signals of impedance plethysmography (IPG), photoplethysmography (PPG), or both, obtained from the patient, to obtain one or more measures of cerebral hemodynamics of the patient, the measures comprising a measure of cerebral blood volume (CBV) and a measure of one or both of cerebral blood flow (CBF) and time to peak (TTP); and

b) applying a rule matching the measure of one or both of CBF and TTP to an extent of a penumbra.

3. A method according to claim 1, wherein applying the rule comprises matching to a choice of thrombolytic therapy, or matching to a choice not to use thrombolytic therapy.

4. A method according to claim 3, wherein applying the rule comprises matching to a choice not to use thrombolytic therapy if hemispheric CBF is above an hCBF threshold.

5. A method according to claim 4, wherein the hCBF threshold is between 20 and 50 milliliters per 100 grams per minute.

6. A method according to claim 3, wherein applying the rule comprises matching to a choice not to use thrombolytic therapy if a ratio of hemispheric to global CBF is above an hCBF ratio threshold.

7. A method according to claim 6, wherein the hCBF ratio threshold is between 80% and 50%.

8. A method according to claim 3, wherein applying the rule comprises matching to a choice not to use thrombolytic therapy if hemispheric TTP is below an hTTP threshold.

9. A method according to claim 3, wherein applying the rule comprises matching to a choice not to use thrombolytic therapy if a ratio of hemispheric to global TTP is below an hTTP ratio threshold.

10. A method according to claim 9, wherein the hTTP ratio threshold is between 1.1 and 2.

11. A method according to claim 3, wherein applying the rule comprises matching to a choice not to use thrombolytic therapy if hemispheric CBV is below an hCBV threshold.

12. A method according to claim 11, wherein the hCBV threshold is between 3 and 4 milliliters per 100 grams.

13. A method according to claim 3, wherein applying the rule comprises matching to a choice not to use thrombolytic therapy if a ratio of hemispheric to global CBV is below an hCBV ratio threshold.

14. A method according to claim 13, wherein the hCBV ratio threshold is between 80% and 50%.

15. A method according to claim 3, wherein applying the rule comprises matching to a choice not to use thrombolytic therapy if regional CBV is above an rCBV threshold.

16. A method according to claim 15, wherein the rCBV threshold is between 1.5 and 2.5 milliliters per 100 grams.

17. A method according to claim 3, wherein applying the rule comprises matching to a choice not to use thrombolytic therapy if a ratio of regional to global CBV is above an rCBV ratio threshold.

18. A method according to claim 17, wherein the rCBV ratio threshold is between 30% and 75%.

19. A method according to claim 1, wherein obtaining and processing the signals is done at least in part outside a hospital setting.

20. A method according to claim 1, wherein the measures comprise an estimate of one or more of global, hemispheric and regional measures of cerebral blood flow (CBF), of cerebral blood volume (CBV), of mean transit time (MTT), and of time to peak (TTP), and mathematical functions of the foregoing parameters singly or in any combination.

21. A method according to claim 1, wherein the signals comprise at least a first signal obtained from a measurement primarily of the left side of the head, and a second signal obtained from a measurement primarily on the right side of the head that is substantially a mirror image of the first measurement, and processing comprises comparing the first and second signals.

22. A method according to claim 1, wherein the one or more signals comprise at least one signal obtained from an impedance measurement made substantially symmetrically or anti-symmetrically with respect to a bilateral symmetry plane of the patient'"'"'s head.

23. A method according to claim 1, wherein processing the one or more signals comprises finding an effective rise time interval of a cardiac cycle.

24. A method according to claim 23, wherein the effective rise time interval begins when the signal first reaches a fixed percentage of the full range of the signal, above a minimum value of the signal.

25. A method according to claim 23, wherein the effective rise time interval ends when the signal first reaches a fixed percentage of the full range of the signal, below a maximum value of the signal.

26. A method according to claim 23, wherein the effective rise time interval ends at a maximum slope of the signal, or at a first inflection point of the signal with positive third derivative, or at a first local maximum of the signal, after the beginning of the effective rise time interval.

27. A method according to claim 23, wherein processing the one or more signals comprises finding an integral of the signal over the effective rise time interval.

28. A method according to claim 27, wherein processing the one or more signals comprises comparing the integral of said signal over the effective rise time interval to an integral of said signal over an effective fall time interval of a cardiac cycle.

29. A method according to claim 23, wherein processing the one or more signals comprises finding a curvature of the signal during the effective rise time interval.

30. A method according to claim 1, wherein processing comprises normalizing a signal to obtain a measure that does not depend on a degree of amplification of the signal.

31. A method according to claim 1, wherein processing comprises normalizing a time interval to a cardiac cycle period.

32. A method according to claim 1, wherein processing comprises using an electrocardiogram (ECG) signal obtained from the patient to calibrate the timing of a feature of an IPG or PPG signal in a cardiac cycle.

33. A method according to claim 1, wherein the one or more signals comprise a signal obtained from a measurement made primarily of one side of the head, and processing comprises using at least said signal to find a measure that is an estimate of a hemispheric or regional cerebral hemodynamic parameter on the same side of the head, or on the opposite side of the head.

34. A method according to claim 33, wherein the hemispheric or regional cerebral hemodynamic parameter is on a side of the head in which clinical evidence indicates a stroke occurred.

35. A method according to claim 1, wherein processing comprises:

a) applying a first algorithm to a first one of the signals to calculate a first measure;

b) applying a second algorithm, the same or substantially the same as the first algorithm, to a second one of the signals, to calculate a second measure; and

c) comparing the first measure and the second measure.

36. A method according to claim 35, wherein the first one of the signals is obtained from a measurement made substantially symmetrically on the head with respect to the bilateral symmetry plane, and the second one of the signals is obtained from a measurement made primarily on one side of the head.

37. A method according to claim 35, wherein the first and second of the signals are both obtained from measurements made primarily on a same side of the head.

38. A method according to claim 35, wherein one of the first and second of the signals is an IPG signal, and the other one is a PPG signal.

2. (canceled)

39. A system for evaluating an acute ischemic stroke in a patient, comprising:

a) an electric current source;

b) at least two sensors adapted to be placed on the patient'"'"'s head, each sensor comprising an IPG electrode structure adapted to pass current from the current source through the head to measure impedance, or comprising a PPG sensor powered by the current source, or both; and

c) a controller which receives one or more waveforms of one or more signals from the sensors, processes the waveforms to obtain one or more measures of cerebral hemodynamics of the patient, and is programmed with software that applies a rule to match said measures to a disease indication or choice of therapy or both, for the patient;

wherein the measures comprise a measure of cerebral blood volume (CBV) and a measure of one or both of cerebral blood flow (CBF) and time to peak (TTP), and applying the rule comprises matching at least the measure of CBV to a size of an ischemia, and matching at least the measure of one or both of CBF and TTP to an extent of a penumbra.

40-56. -56. (canceled)